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Revolution Medicines early access for daraxonrasib
Revolution Medicines started shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for pancreatic cancer. CEO Mark Goldsmith told STAT the company is now...
Pfizer–Innovent oncology mega-deal
Pfizer and Innovent Biologics announced a collaboration valued at up to $10.5 billion, covering a portfolio of 12 early-stage and de novo antibody-drug conjugates and multispecific oncology...
Allogene CEO transition
Allogene Therapeutics said Zachary Roberts will succeed David Chang as president and CEO on July 1. Roberts will also join the board and currently serves as EVP of R&D and CMO at the off-the-shelf...
CAR-T company strategy reset
Legend Biotech founder Frank Fan is returning to ASCO with a new CAR-T platform plan aimed at high-yield manufacturing and non-gene-editing approaches, according to reporting on his new ambition....
Bristol Myers next-gen myeloma drug readout
Bristol Myers Squibb presented Phase 3 results for mezigdomide in the SUCCESSOR-2 study in relapsed or refractory multiple myeloma. In the trial, adding mezigdomide to carfilzomib and...
ASCO: iDFS improvement with oral SERD giredestrant
Giredestrant showed invasive disease-free survival benefits across menopausal status in lidERA, a randomized trial in high-risk stage I–III ER+/HER2− early breast cancer. The study compared...
Puxitatug samrotecan ADC in endometrial cancer
Puxitatug samrotecan, a B7-H4-directed antibody-drug conjugate, produced high response rates in B7-H4-expressing recurrent or progressive endometrial cancer in the BLUESTAR phase 1/2a trial. At...
Tempus FDA approval for tumor-only NGS indication
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can profile solid tumors with comprehensive genomic...
Oncology drug development and trial readouts
Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for advanced pancreatic cancer, with the drug still unapproved. The step...
Breast cancer adjuvant endocrine strategy expansion
New interim and subgroup results from the lidERA Phase 3 trial show giredestrant reduced invasive disease or death versus standard-of-care endocrine therapy across both premenopausal and...
Endometrial and ovarian targeted ADC acceleration
Puxitatug samrotecan (AZD8205) generated high response rates in B7-H4–selected recurrent or progressive endometrial cancer in the BLUESTAR Phase 1/2a program, including a 47.1% confirmed objective...
Multiple myeloma combination and next-gen pipeline validation
Bristol Myers Squibb unveiled Phase 3 results for mezigdomide plus carfilzomib and dexamethasone (MeziKd) in relapsed or refractory multiple myeloma under its SUCCESSOR-2 program. The mezigdomide...
Prostate cancer regimen upgrade with PARP–AR pathway pairing
Pfizer reported detailed Phase 3 TALAPRO-3 results showing talazoparib (TALZENNA) plus enzalutamide (XTANDI) improved radiographic progression-free survival in HRR gene–altered metastatic...
Regulatory debate over multicancer early detection assays
ASCO said it will not recommend Grail’s Galleri test for population screening after the NHS-Galleri trial failed to meet its primary endpoint. The decision comes as the controversy continues over...
Oncology biomarkers in early testicular cancer surveillance
A SWOG prospective cohort study reported interim results on microRNA-371a-3p (miR371) as a relapse predictor in early-stage testicular cancer patients managed with active surveillance. The...
FDA and regulatory policy: user fees and agency acceleration
The White House is reviewing a new FDA user fee deal that would set prescription drug user fees for 2028 through 2032, according to sources cited in the report. The development adds another...
Biopharma licensing and platform deals in ADCs and multispecifics
Pfizer struck a major oncology licensing collaboration with China’s Innovent Biologics covering 12 antibody-drug conjugates and multispecific programs, including eight Innovent early-stage assets...
Company leadership transition in cell therapy
Allogene Therapeutics announced that its chief medical officer, Zachary Roberts, will succeed David Chang as president and CEO on July 1, with Roberts joining the board while Chang remains on the...
Oncology drug approvals/registrations and regulatory pathways
FDA approval for a tumor-only next-generation sequencing approach for solid tumors marks a practical shift in how comprehensive genomic profiling can be deployed in routine care. Tempus AI said...
Large licensing deals reshaping oncology pipelines
Pfizer and Innovent Biologics escalated their global oncology collaboration with a deal sized up to $10.5 billion, anchoring the partnership around next-generation antibody-drug conjugates and...